Apparatus and method for connecting a conduit to a hollow organ

ABSTRACT

An apparatus and method for connecting a first conduit to the heart without cardiopulmonary bypass. The first conduit may be attached to a second conduit having a prosthetic device interposed. The second conduit may then be connected to the aorta. The prosthetic device may be a prosthetic valve (or pump). The apparatus includes an implantable connector with first conduit component, a coring component, a retractor expansion component slidably coupled to the coring component, and a pushing component. The retractor expansion component seats against and separates the inside wall of the left ventricle so that the coring component cuts cleanly through the myocardium, forming a tissue plug. By remaining seated against the inside wall, the retractor expansion component follows the tissue plug into the coring component. The surgeon applies force and rotary motion to the pushing component sufficient to cut the tissue plug and implant the prosthetic component.

RELATED APPLICATIONS

This application claims priority of U.S. Provisional Application Ser.Nos. 60/555,308, filed Mar. 23, 2004; 60/635,652 filed on Dec. 14, 2004and 60/636,449 filed on Dec. 15, 2004.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an apparatus and method for connectinga conduit to a hollow organ, and more particularly, to a surgical deviceconnectable to the apex of a heart.

2. Description of the Related Art

As the average age of the United States population increases, so do theinstances of aortic stenosis. An alternative approach to theconventional surgical replacement of the stenotic aortic valve involvesthe use of an apicoaortic conduit. In this approach, the native aorticvalve is not removed, and a prosthetic valve is implanted in a parallelflow arrangement. A connection conduit (or tube) connects the apex ofthe heart to the descending aorta. Somewhere along this conduit, theprosthetic valve is interposed. Thus, blood leaves the heart through theapex and travels through the conduit (with valve) to the descendingaorta.

Until recently, surgical procedures to implant an apicoaortic conduithave included a single, long incision, such as in the 6^(th) intercostalspace, to expose the heart and allow retraction of the lungs to exposethe descending aorta. Recognizing the potential for broader scale use ofthe apicoaortic conduit for aortic valve replacement, some surgeons arenow attempting to use smaller incisions and are requesting developmentof surgical tools for a minimally invasive procedure. As an initialattempt to make the procedure less invasive, some surgeons have recentlyperformed the following procedure.

The patient is placed on the table in the supine position. Anesthesia isinduced, and the patient is intubated with a double-lumen endotrachealtube, this facilitates one-lung ventilation and allows the surgeon towork within the left chest. The patient is positioned with the left sideup (90 degrees). The pelvis is rotated about 45 degrees, such that thefemoral vessels are accessible. An incision is made over the femoralvessels, and the common femoral artery and vein are dissected out.Heparin is administered. Pursestring sutures are placed in the femoralartery and vein. The artery is cannulated first, needle is inserted intothe artery, and a guidewire is then inserted. Transesophageal echo isused to ascertain that the wire is in the descending aorta. Once this isconfirmed, a Biomedicus arterial cannula is inserted over the wire, intothe artery (Seldinger technique). The arterial cannula is typically 19or 21 French. Once inserted, the pursestring sutures are snugged downover tourniquets. A similar procedure is followed for the femoral vein.The venous cannula is usually a few French larger than the arterialcannula. Once both vein and artery are cannulated, the cannulae areconnected to the cardiopulmonary bypass, and the capability to initiatecardiopulmonary bypass at any time is present.

A 1 cm incision is made in approximately the 7^(th) interspace in theposterior axillary line; the videoscope (10 mm diameter) is inserted,and the left chest contents viewed. The location of the apex of theheart is determined, and the light from the scope used totransilluminate the chest wall; this allows precise localization of theincision. The incision is then performed; it is essentially an anteriorthoracotomy, typically in the 6^(th) interspace. Recent incisions havebeen about 10 cm long, but are expected to become smaller and smallerwith time. A retractor is inserted and the wound opened gently. A lungretractor is used to move the (deflated) left lung cephalad. Thedescending aorta is dissected free from surrounding soft tissue toprepare for the distal anastomosis. This dissection includes division ofthe inferior pulmonary ligament. A pledgeted suture is placed on thedome of the diaphragm and positioned to pull the diaphragm toward thefeet (out of the way). The pericardium is incised about the apex of theheart, and the apex is freed up and clearly identified.

On the back table, the apicoaortic conduit is prepared: a 21 freestylevalve is sutured to an 18 mm Medtronic apical connector. The valve isalso sutured to a 20 mm Hemashield graft. The Dacron associated with theapical connector is pre-clotted with thrombin and cryoprecipitate. Theassembly is brought to the field, and a measurement made from the apexof the heart to the descending aorta. The assembly is trimmedappropriately. A partial-occluding clamp is then placed on thedescending aorta, and the aorta opened with a knife and scissors. Theconduit (the end with the 20 mm hemashield graft) is then sutured to thedescending aorta using 4-0 prolene suture, in a running fashion. Oncethis is complete, the clamp is removed and the anastomosis checked forhemostasis. Blood is contained by the presence of the freestyle aorticvalve. The apical connector is placed on the apex, and a marker is usedto trace the circular outline of the connector on the apex, in theplanned location of insertion. Four large pledgeted sutures (mattresssutures) of 2-0 prolene are placed; one in each quadrant surrounding themarked circle. The sutures are then brought through the sewing ring ofthe apical connector. A stab wound is made in the apex in the center ofthe circle, and a tonsil clamp is used to poke a hole into theventricle. To date, bypass has been initiated at this point, but doingso may not be necessary. A Foley catheter is inserted into theventricle, and the balloon expanded. A cork borer is then used to cutout a plug from the apex. The connector is then parachuted down intoposition. A rotary motion is necessary to get the connector to seat inthe hole. The four quadrant sutures are tied, and hemostasis is checked.If there is a concern regarding hemostasis, additional sutures areplaced. The retractor is removed, chest tubes are placed, and the woundis closed.

Surgical tools developed specifically to implant the apicoaortic conduitare expected to provide the means for a much less invasive procedure.The procedure is expected to be performed with a series of smallerthoracotomy incisions between the ribs, such as immediately over theapex of the heart. In addition to avoiding the median sternotomy,development of appropriate surgical tools is expected to avoid the needfor cardiopulmonary bypass, so that the procedure can be performed on abeating heart. The diseased aortic valve does not need to be exposed orexcised. The stenotic aortic valve is left in place and continues tofunction at whatever level it remains capable of, and the apicoaorticconduit accommodates the balance of aortic output.

The major obstacle, to widespread adoption of this superior technique isthe nearly complete lack of efficient devices to perform the procedure.Surgeons wishing to adapt the procedure must gather a collection ofinstruments from a variety of manufacturers. Often these instrumentswere created for quite different purposes, and the surgeon is forced toadapt them as required and manually manipulate them during a procedure.

U.S. Published Patent Application 2003/0130668 A1 (Nieman) describes amethod and apparatus for remotely cannulating a body part, such as aheart. The method and apparatus are endoscopic, i.e the instruments aremounted on the end of a long flexible member and inserted into the bodythrough a trocar, i.e., a sharply pointed surgical instrument containedin a cannula. The endoscopic procedure is complicated. After the deviceis placed at or near the apex of the heart, the surgeon or some othercontroller performs at least 13 separate steps to secure the cannula inthe heart wall. An attachment ring (which includes an apical ring and alocking stem) is sutured to the heart wall, and subsequently the cannulais connected to the attachment ring as a separate step. Because theprocedure is endoscopic, imaging means (e.g., fluoroscopy) is used toplace a balloon at the correct depth within the ventricle to provideocclusion.

The complex endoscopic procedure disclosed in Nieman appears to requirethat the cut tissue core be removed from the body prior to advancing thecannula to the heart wall. Further, Nieman appears to provide twomechanisms for placing the cannula in the heart wall. One such mechanismis to create a hole that is large enough to easily slide the cannulainto the hole. This does not provide a tight fit between the cannula andcored heart wall to prevent blood loss from the cored heart wall andfrom the ventricle and relies entirely upon the sutured attachment ringto achieve hemostasis thus providing a period of time during which therecould be great losses of blood. The second mechanism is to achieve atight (interference) fit between the cannula and cored hole. However,such a tight fit requires substantial axial and torsional forces to beapplied to the cannula. The flexible endoscopic instrument disclosed inNieman cannot provide such forces to be transmitted

U.S. Patent Publication No. 2004/0162608 (Haverich) discloses a methodand apparatus for implanting a conduit into the wall of a heart. Asillustrated in FIG. 8A, Haverich shows a conduit on a cutter that has a“corkscrew driver” with a coil. The corkscrew is rotated to cause thecutter to penetrate through the myocardium. However, substantial axialforce is required to cleanly penetrate the myocardium, and such force isnot easily applied by a corkscrew. Further, the pointed tip of thecorkscrew can damage other areas of the heart wall (e.g., the septum)while applying axial force and rotation. Haverich discloses a balloonused for hemostasis. However, the balloon is a separate instrument thatcannot be combined with the corkscrew.

U.S. Patent Publication No. 2002/0045846 (Kaplon) discloses a devicesimilar to Haverich except that a trocar is used to penetrate the organwall instead of a cutter with corkscrew. No tissue plug is formed with atrocar. Use of a trocar makes it difficult to achieve hemostasis duringa procedure-on a beating heart. To address this, rigid conduit 18 isinserted through the connector 16 after the connector is implanted withthe trocar and sewn into place. Connector 16 does not appear topenetrate the heart wall. Connector 16 has a built-in valve to preventblood loss after the trocar is removed and until conduit 18 is inserted

SUMMARY OF THE INVENTION

A connector conduit according to the preferred embodiment includes arigid apical connector portion which will serve to provide egress fromthe left ventricle (such as from the apex or lateral wall), a flexibleconduit portion which will carry blood from the connector to thearterial system (such as to the descending thoracic aorta or theascending thoracic aorta), and the aortic valve itself, which will besituated somewhere within the conduit. The present invention primarilyaddresses implantation of an apical connector with an attached length ofconduit, referred to herein as the connector conduit (or connector). Theconnector conduit is implanted using an applicator. Although thisdiscussion focuses primarily on the apex of the left ventricle, it isunderstood that the present invention can be used to implant a connectorconduit to any wall of the left ventricle or other hollow organ.

As described earlier, the surgeon conventionally uses a cork borer tocut a tissue plug from the ventricle wall. Once the tissue plug isremoved, the surgeon must attempt to occlude the resulting hole, such aswith a finger, a balloon or some other occlusion means, until theconnector conduit is inserted. Despite attempts to occlude the resultinghole, substantial blood loss is inevitable. Cardiopulmonary bypass isused to reduce blood loss.

An object of the present invention is to integrate the cork borer andconnector conduit to form a system in which the connector conduit isinserted into the ventricle wall as the tissue plug is being created,thereby eliminating the need for a separate occlusion means and greatlyreducing blood loss. Such integration may be achieved by mounting theconnector conduit directly onto the outer diameter of a coring elementor integrating the cutter and the connector conduit, which cuts thetissue plug and occludes blood flow through the inner diameter. In thisway, the cross sectional area for blood loss is reduced to the gapbetween the coring element and connector conduit.

Another object of the present invention is to combine the coring elementwith other features to form a complete applicator for securing theconnector conduit into the ventricle wall. These features may include amounting element and a handle element. The mounting element is anextension to the coring element that serves to add axial length to thecoring element onto which the full length of the connector conduit maybe mounted. The mounting element may be of the same diameter as thecoring element. The handle element provides a grip to facilitate thenecessary positioning, twisting and pushing force necessary to cut thetissue plug and to insert the connector into the ventricle wall. Thehandle could have a pistol handle shape, for example.

Another object of the present invention is to provide the option foradditional features for the complete applicator system for securing theconnector conduit into the ventricle wall, particularly at the apex.These additional features may include a retractor element and a quickconnect coupling element.

The refractor element may have an expanding element for: 1) shaping theapex of the ventricle into a preferred shape for cutting the tissueplug, 2) providing a backing surface for the coring element in order tosandwich the heart wall between the coring element and expandingelement, 3) pulling the tissue plug to within the coring element, and/or4) ensuring that the tissue plug remains inside the coring element. Theexpanding element could be a liquid-inflated balloon sponge, or amechanically-operated umbrella, as examples.

The expanding element is mounted onto the retractor element, and theretractor element is slide-ably mounted within the coring element. Acoupling element, such as a compression spring, provides the force tomove the retractor element relative to the coring element. The retractorelement may be designed to prevent relative rotation between theexpanding element and coring element, thereby reducing the likelihood ofdamage to the expanding element. The retractor element may also includea section of increased diameter that abuts the outer heart wall toprevent premature or undesired cutting of the ventricle wall bypreventing contact between the coring element and ventricle.

Another object of the present invention is to provide an expandingelement that has a similar look and feel as the conventional procedure.For example, the expanding element may be a balloon. A syringe elementmay expand the expanding element to a predetermined level by inflationwith a liquid. To minimize the space required for the syringe, theballoon may be designed specifically to require minimal inflation volumewhile still performing the necessary functions of the expanding element.In addition, a filling element of the applicator may provide the meansto fill the syringe element and balloon from an external liquid sourceand to provide the means to purge air from the expanding element.

Another object of the present invention is to provide a connectorconduit that has many of the features of the conventional apicalconnector (e.g., Medtronic™ apical connector) and includes additionalfeatures to make it compatible with the applicator and the surgicalprocedure. Additional features to make the connector conduit compatiblewith the applicator include 1) an ability to straighten the connectorconduit from a bent configuration so that it will slide onto a straightmounting element, 2) a modified leading edge on the connector to easeinsertion into the heart wall, and 3) a clamping element that includesportions of both the connector conduit and the applicator which servesto lock the connector conduit to the applicator in a predeterminedposition and to facilitate applying the twisting and pushing forcenecessary to insert the connector.

An additional feature of the connector conduit to make it compatiblewith the surgical procedure is a quick connect coupler to expediteattachment of the connector conduit to the remainder of the prosthesis,which includes the prosthetic valve. The quick connect coupler isnecessary to prevent a long time delay between implanting the connectorconduit into the ventricle and achieving blood flow through the completeprosthesis. Such quick connect coupler may consist of a first part thatis attached to the connector conduit and a second part that is attachedto the remainder of the prosthesis, which includes the prosthetic valve.

An additional feature of the connector conduit to make it compatiblewith the surgical procedure is to provide a length of conduit that maybe collapsed, such as with an occlusion clamp, to prevent blood flowthrough the connector conduit before the quick connect coupler isconnected and the surgeon is ready to allow blood flow through thecomplete prosthesis.

In one configuration of the invention, expansion of the expandingelement and the position of the retractor element are controlledindependently by the surgeon. For example, if the expanding element is aballoon connected to a syringe, the volume of liquid in the balloon iscontrolled by the position of the plunger inside the syringe. Similarly,a bolt may be used to control the position of the retractor elementrelative to the coring element. In this configuration, the surgeon mustindependently control the positions of the syringe plunger and theretractor element bolt.

Another configuration of the present invention provides a sequencingelement (such as a cam mechanism) that ensures that critical steps ofthe procedure are performed in the proper sequence. The sequencingelement synchronizes expansion of the expanding element with position ofthe retractor element. The sequencing element includes a sequencingbolt. The surgeon uses one hand to hold the applicator handle and theother hand to slide the sequencing bolt. In this way, independentcontrol of the expanding and retractor elements is eliminated.Independent positions of these components are not user driven; rather,positions of these components are synchronized by the sequencingelement. One example of a sequencing element is described next; however,it is understood that a sequencing element may be used to control fewersteps or additional steps of securing the connector conduit into theventricle wall.

The system is set up with the connector conduit mounted onto theapplicator and with the retractor fully extended. The procedure beginsby making a small knife wound in the apex and pushing the retractorelement (with fully-deflated expanding element) through the heart walland into the ventricle. The surgeon slides the sequencing bolt from afirst position to a second position. Once the sequencing bolt is in thesecond position, the surgeon may release the sequencing bolt. Thesequencing element ensures that this sliding motion serves to firstexpand the expanding element and, after the expanding element is fullyexpanded, to release the retractor element so that the retractor elementcan move the expanding element relative to the coring element. Thesurgeon may now use the handle to apply twisting and pushing force toplace the connector conduit into the ventricle wall. During this time,the sequencing element simultaneously coordinates:

-   -   a. application of compressive force between the expanding        element and the coring element, thereby sandwiching and shaping        the heart wall for cutting the tissue plug,    -   b. the coring element to cut a hole in the ventricle wall,        thereby creating a tissue plug,    -   c. insertion of the connector conduit into the hole, and    -   d. the retractor element to retract the tissue plug from the        hole into the coring element.

Once the tissue plug is created, the sequencing element partiallyreduces the diameter of the expanding element so that the expandingelement can enter the inner diameter of the coring element whileremaining of large enough diameter to prevent the tissue plug fromsliding off of the retractor element. This change in diameter of theexpanding element occurs automatically to a pre-set intermediatediameter without attention from the surgeon. Once the surgeon has placedthe connector conduit at the desired position within the ventricle wall,the applicator may be removed.

In a preferred configuration, the connector conduit is a fabric (e.g.,Dacron) covered device that is specifically designed for insertion intothe wall of the left ventricle, such as at the apex. It contains astructural frame, a sewing flange (or suture ring) for attachment to theheart, and a standard fabric (e.g., Dacron) flexible vascular graft thatextends through the lumen of the entire length of the structural frameand for some additional length beyond. An outer fabric may also coverthe outside of the structural frame. The components of the connectorconduit are interconnected, such as with polyester thread. The fabricmay include orientation marks, such as a line along the length of theconduit. In addition, a quick connect coupling may be used to attach theconnector conduit to the remainder of the prosthesis, which includes theprosthetic valve or ventricular assist device, as examples.

A function of the structural frame is to provide mechanical integrity,i.e., rigidity, for the connector conduit. The structural frame mayinclude a leading edge, a cage, a bend, and a holder. The leading edgeis the first portion of the structural frame to be pushed through theheart wall. To minimize effort needed to push the connector through theheart wall, such leading edge may be tapered and/or beveled, forexample. The cage is the portion of the structural frame that resideswithin the heart wall. The bend is the portion of the structural framethat holds the conduit in a preferred shape to direct blood flow fromthe left ventricle to the aorta, as described next in more detail. Theholder is the portion of the structural frame that provides a means ofmechanical connection between the connector conduit and applicator.

The bend in the structural frame may be any appropriate angle (such as90 degrees) to properly direct the conduit from the ventricle to theportion of the aorta where the conduit is to be connected. For example,the bend in the structural frame may be around 90 degrees if the conduitis to be connected to the descending thoracic aorta, or a larger anglebend may be used if the conduit is to be connected to the ascendingthoracic aorta, for example. As described next, such bend may beflexible or rigid.

In one embodiment, the bend of the structural frame may be flexible. Forexample, a set of equally-spaced circular rings mounted perpendicularlyon a spine could form a bend that can flex to a range of angles. Thecircular rings provide radial support to prevent collapse of the conduitdue to external forces. The spine may be at the outer radius of the bendor at the inner radius of the bend, as examples. In this embodiment, thebend can be straightened out from a preferred angle such that a mountingelement of the applicator may be inserted straight through the lumen ofthe connector. Upon removal of the mounting element, if the bend isconstructed of a material with a relatively high modulus of elasticity(e.g., PEEK), the connector returns to its bent configuration. If thebend is constructed of a material with a relatively low modulus ofelasticity (e.g., polypropylene, polyethylene), the connector forms thebent configuration only when an external force is applied, such as by abending means. Such bending means could involve pulling on threads thatare weaved through the circular rings so that the bend is formed whenthe threads are pulled, for example. When the bend is at the preferredangle, the user may tie or crimp the threads together, for example,thereby preventing straightening of the bend. Such bending means allowsthe user to select any one of a plurality of possible bend angles as thepreferred angle. Such bending means may also be used with a bendconstructed of a material with a relatively high modulus of elasticity,such as to prevent straightening beyond the preferred angle.

In another embodiment, the bend of the structural frame may be rigid. Inthis embodiment, since the bend cannot be straightened out, the bendmust include a port such that the mounting element of the applicator maybe inserted through such port and through the lumen of the cage. In thisembodiment, the conduit must include a branch of additional conduit toform a Y. Such additional branch of conduit is coaxial with the cage formounting the connector conduit onto the applicator. Once the connectorconduit is implanted into the heart wall and the applicator is removed,the branch of conduit is occluded, such as by sewing or stapling theconduit closed, for example. The branch is then removed, such as bycutting with scissors.

In another embodiment of the connector conduit, a quick connect couplermay be used to attach the connector conduit to the remainder of theprosthesis, which includes the prosthetic valve. The complete prosthesismay be divided into two parts: a first part that includes the prostheticvalve with lengths of conduit attached to both the upstream anddownstream sides of the prosthetic valve and a second part that includesthe connector conduit. The quick connect coupler allows the surgeon torapidly connect said first part to said second part. In this way, thesurgical procedure may be performed by first attaching said first partof the complete prosthesis to the aorta. Then, after the connectorconduit is secured into the ventricle wall, the quick connect couplerallows rapid completion of the flow circuit to minimize the time betweeninsulting the heart by cutting the hole and reducing the work load onthe heart by allowing blood flow through the prosthesis.

An applicator is used to implant the connector conduit into theventricle wall. In a preferred embodiment, the applicator providesmechanical support on the surfaces of both the inner diameter and theouter diameter for some portion of the fabric-covered structural frame.Such support may be necessary to avoid unwanted distortion or movementof the structural frame while the connector conduit is being implantedthrough the heart wall. For example, the mounting element of theapplicator, which is inserted straight through the lumen of theconnector, may provide mechanical support (such as radial support) onthe inner-diameter surface to reduce distortion of the structural frameduring implantation. On the outer-diameter surface, the applicator mayinclude a concentric tubular structure, referred to as the pushingelement. The pushing element provides mechanical support (such as radialsupport) on the outer-diameter surface of the structural frame to reducedistortion during implantation. In a preferred embodiment, the mountingelement and the pushing element are rigidly connected.

In a related embodiment, an indexing means provides an interface betweenthe pushing element and connector conduit that may prevent or greatlyreduce rotation and/or axial movement of the connector conduit relativeto the pushing element. As such, rotary or axial force applied to thepushing element is transmitted to the connector conduit through thelocking means. An effective locking means may incorporate portions ofthe pushing element, mounting element and connector conduit. Forexample, the indexing means may include a slot-and-key arrangementthat 1) positions the connector conduit at a preferred angle relative tothe pushing element thereby orienting the bend in the structural frame,2) prevents axial and rotary motion of the connector conduit relative tothe pushing element, and 3) allows the connector conduit to be easymounted onto and released from the applicator. Such indexing means mayinclude a pushing element with an adjustable diameter that allows bothrigid mounting and unhindered release of the connector conduit. Suchindexing means may also include a connector conduit with a holder thatlocks to the pushing element, such as with a slot-and-key arrangementand/or with a tight friction fit, as examples. Such holder may besandwiched firmly between the mounting element and pushing element.

In a preferred configuration, the mounting element extends from a coringelement that shares the same axis and has the same outer diameter as themounting element. The coring element is used to cut a hole into theheart wall. Such coring element could consist of a thin-walled tube, theleading edge of which has been sharpened or serrated. The inner diameterof the connector conduit could fit snugly on the outer diameter of thecoring element and mounting element. In use, the coring element couldproduce a hole in the heart wall that is smaller than the outer diameterof the connector conduit, thereby producing a snug fit.

In a related embodiment, a handle may be rigidly attached to the pushingelement. The handle may be at a substantially right angle after themanner of a pistol grip, for example. Such a handle attachment providesa more effective method of applying the insertion force andback-and-forth rotation needed to implant the connector conduit.

In a preferred configuration, located concentrically within the mountingelement is a retractor element consisting of a generally tubularstructure having a pointed end that is inserted through the leftventricle wall. The tubular structure could be rigid. In a preferredembodiment, the pointed end of the retractor element could be a bluntedpoint. In this way, after a small knife wound is made in the epicardium(outer surface of the heart), the blunted point could enter the knifewound and divide muscle fibers to penetrate the myocardium and leftventricle chamber. A purpose of the blunted point is to reduce thelikelihood of damage should the point unintentionally contact otherareas of the inner wall during use. In an alternative embodiment, theretractor element could include a very sharp pointed end being capableof producing its own entrance hole into the wall of the heart.Alternately, it could have a blunted point that would simply follow apreviously created hole through the entire thickness of the ventriclewall. If so desired, the tubular structure of the retractor allows useof a guide-wire to follow a previously created hole.

Near the pointed end of the retractor element is an expanding element,such as an inflatable balloon, an unfolding umbrella-like construction,an expandable collar, or similar structure. Once inside the ventricle,the expanding element is expanded from an initial diameter that mayapproximate the outer diameter of the retractor element to a seconddiameter. In a preferred configuration, the expanding element expands toa second diameter that is larger than the outer diameter of the coringelement. The expanding element expanded to its second diameter seatssnugly against the inside wall of the ventricle. Functions of theexpanding element may include 1) expanding symmetrically to shape theinner wall of the ventricle into a preferred shape for cutting thetissue plug, and 2) fully retracting to within the coring element whileremaining at least partially expanded.

A first function of the expanding element is symmetric expansion, whichprovides at least two benefits. The first benefit is related to thevariable, cone-shaped geometry of the left ventricular chamber near theapex. Symmetric expansion of the expanding element to a diameter that islarger than the outer diameter of the coring element effectivelyflattens out the ventricle wall in the vicinity of the apex so that theventricle wall is more perpendicular to the sharpened leading edge ofthe coring element, thereby allowing the coring element to cut throughthe entire thickness of the ventricle wall. The tubular structure of theretractor element must resist the radial reaction forces from theventricle walls. The second benefit of symmetric expansion is to ensurecontact between the expanding element and the leading edge of the coringelement along its entire circumference as the tissue plug is formed.Asymmetric expansion of the expanding element can result in formation ofa plug with hanging attachments to the left ventricle wall.

A second function of the expanding element is to fully retract andretain the plug within the coring element after the plug is cut. Suchfull retraction ensures that the applicator will slide out of theconnector conduit (after the connector is implanted) without the plugand expanding element coming into contact with the inner diameter of theconnector conduit. Such contact could increase the force required toremove the applicator from the connector conduit and could possiblyresult in debris from the removed plug being deposited on the innerdiameter of the connector conduit. In addition, the expanding elementmust remain at a large-enough diameter after being retracted to withinthe coring element to ensure that the plug cannot slide off the end ofthe retractor element.

In a related embodiment, this second function could include a couplingelement that forces the retractor element to retract within the mountingelement. In a preferred configuration, the coupling element could be acompression spring, for example. In this configuration, the retractorelement could be slide-ably connected to the mounting element by meansof the compression spring. The force produced by the compression springtends to pull the expanding element snugly against the inside wall ofthe ventricle and to pull the tissue plug into the coring element afterthe tissue plug is detached from the ventricle. Alternatively, the usercould manually provide the necessary force to retract the retractorelement to within the coring element.

In a preferred embodiment, the expanding element can be: 1) initially ata first diameter that approximates the outer diameter of the retractorelement, 2) expanded to a second diameter that is larger than theoutside diameter of the coring element, and 3) then reduced to a thirddiameter that is smaller than the inside diameter of the coring elementbut larger than the outer diameter of the retractor element. Inflationto the second diameter accommodates the first function of the expandingelement (described above), and reducing to the third diameteraccommodates the second function of the expanding element (describedabove).

In a preferred embodiment, the expanding element is a balloon. Theballoon may be inflated using an access means, such as a plunger incylinder configuration (like a syringe) connected to the balloon by aflow passage, such as a channel integrated into the retractor element.An appropriate fluid to inflate the balloon could be saline, forexample. The balloon material should be selected to best perform thefunctions of the expanding element. Polyurethane is a preferredmaterial. Polyurethane is an elastic material that allows a balloon tobe expanded symmetrically to as much as twice the original volume usinga hand-held syringe. Such balloons are strong, abrasion resistant, anddurable. Use of latex, another elastic material, is less desirable.Latex balloons typically expand asymmetrically, so use of a latexballoon as the expanding element could necessitate a means integratedinto the balloon to ensure symmetric expansion. In the presentinvention, a latex balloon could be inflated to a symmetric diameter asdetermined by tension rods or sutures, for example, attached to theballoon and the retractor element. Once the tissue plug is formed, theplunger could be displaced to reduce the size of the balloon to allowretraction into the coring element. A means to prevent damage to thelatex balloon by the coring element may be used. Alternatively, theballoon may be constructed of polyethylene terephthalate (PET; tradenames include Dacron and Mylar), which is a non-elastic material.Balloons made of PET may be symmetrically inflated to higher pressureswithout appreciable change in the balloon volume.

In one configuration of the present invention, expansion of theexpanding element and the position of the retractor element arecontrolled independently by the surgeon. Consider the example of using aballoon as the expanding element. Inflation of such balloon could befully controlled by the surgeon, such as by using a finger to displace aplunger inside a cylinder. In such case, the surgeon could inflate theballoon to any volume up to the maximum volume of the plunger/cylinder.Also in this configuration, the position of the slide-able retractorelement relative to the coring element may be independently controlledby means of a bolt attached to the retractor element that passes throughan indexed slot in the mounting element. In a preferred embodiment withthe mounting element rigidly connected to a pushing element, the indexedslot could be in such pushing element. As the bolt is moved from oneindexed position in the slot to another, the retractor is advanced orretracted relative to the coring element. In a preferred configurationwith compression spring coupling between the retractor element andcoring element, an indexed slot with the retractor element fullyadvanced (ready for insertion into the left ventricle wall) could beused. The bolt could then be manually released from the indexed slotafter inflating a balloon on the retractor element. The compressionspring would then pull the balloon firmly against the inner heart wall,thereby sandwiching the heart wall between the balloon and coringelement.

Independent control of the expanding element and retractor element couldrequire increased surgeon training to ensure operation of these elementsin the proper sequence. Alternatively, various latching or locking meanscould be used. For example, once the balloon has been inflated to apreset maximum volume, a latching means could lock the plunger intoplace, thereby preventing unintentional deflation of the balloon. Ifnecessary, deflation to an appropriate volume for retraction into thecoring element could be automatically triggered when the retractorelement reaches a preset position during retraction. Alternatively,inflation and deflation of such balloon to preset maximum and reducedvolumes could occur automatically, such sequence being initiated bypressing a spring-loaded trigger that displaces the plunger, forexample. In addition, a safety latch or other means could prevent manualrelease of the bolt until the expanding element is fully expanded. Theseseparate latching or locking means could result in a complicatedmechanical configuration.

In a preferred configuration of the present invention, a sequencingelement, such as a cam mechanism, is used to coordinate expansion of theexpanding element with position of the retractor element. Control of theexpanding element and control of the retractor element position arecoordinated so that the surgeon need only move a single sequencing boltto control both the expanding element and the retractor element. Thespecific actions of the expansion element and retractor element that arecontrolled by the sequencing element may be chosen by the devicedesigner to best accommodate the degree of control preferred bysurgeons.

In one embodiment of a preferred configuration that includes asequencing element, the cylinder used to inflate/deflate the balloon(the syringe cylinder) may be integrated into the retractor element.Thus, the syringe cylinder, retractor element, balloon, and flow passageconnecting the syringe cylinder to the balloon are integrated into asingle component, referred to as the retractor assembly. The plungerused to inflate/deflate the balloon (the syringe plunger) may include asequencing bolt extending radially from the plunger axis. Suchsequencing bolt also extends radially through a slot in the syringecylinder. As such, the slot in the syringe cylinder limits axialmovement of the plunger in the syringe cylinder. By having a pluralityof circumferentially interconnected slots of various axial lengths inthe syringe cylinder, the degree of balloon inflation may be controlledby moving the sequencing bolt to a preferred axial slot. Synchronizationof balloon inflation/deflation with motion of the retractor assemblyrelative to the pushing element (which is rigidly connected to themounting element) may be achieved with two cam slots in the pushingelement, for example. The first cam slot controls motion of a camfollower rigidly attached to the retractor assembly, thereby controllingthe position of the retractor assembly relative to the pushing element.The second cam slot synchronizes inflation/deflation of the balloonrelative to the position of the retractor assembly within the pushingelement. The sequencing bolt serves as the cam follower in the secondcam slot. Safety features may be integrated into the design of the cammechanism. For example, the cam and follower can be designed to preventmovement of the retractor assembly relative to the pushing element(which is rigidly connected to the coring element) until the balloon isfully inflated.

Various other features may be included to ensure safety and proper useof the connector conduit with applicator. For example, a port with atwo-way valve may be integrated into the plunger/cylinder with balloonsystem to allow for filling with fluid and removal of air. As anotherexample, a mounting tool may be used to mount the connector conduit overthe coring element without damage to the fabric. As another example, afolding tool may be used to squeeze fluid from the balloon and to foldthe balloon for use. As another example, the mounting tool and foldingtool may be integrated into a single tool.

The invention facilitates procedures using an integral device in whichthe various steps are preformed in a coordinated, i.e. sequenced manner.This renders the procedure simple and safe and reduces the likelihood oftissue damage or other complications. Other features and advantages ofthe invention will be apparent from the detailed description and fromthe claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an apicoaortic conduit.

FIG. 2A is a perspective view of the structural frame of one embodimentof a connector shown in a bent configuration.

FIG. 2B is a perspective view of the structural frame of the connectorof FIG. 2A shown in a straight configuration.

FIG. 3A is a cross-sectional view another embodiment of the structuralframe of the connector, covered in fabric, with an incorporated sewingflange and shown in the bent configuration.

FIG. 3B is a cross-sectional view of the structural frame of theconnector of FIG. 3A shown in a straight configuration.

FIG. 3C is a cross-sectional view of the connector of FIG. 3A shown inthe straight configuration, and with a fabric conduit in place.

FIG. 4 is a cross-sectional view of an embodiment of the device showingthe coring element and the retractor element in place within thestraightened connector.

FIG. 5 is a cross-sectional view of a cylinder plug tool that slidesover the retractor element and into the coring element, which is used toload the connector-conduit onto the coring element.

FIG. 6 is a cross-sectional view of an embodiment of the device showingthe placement of a compression spring between the retractor element andthe coring element.

FIG. 7 is a cross-sectional view of another embodiment of the deviceshowing the placement of a pushing element.

FIG. 8A is a cross-sectional view of yet another embodiment of thedevice showing the attachment of a handle to the pushing element with anaccess means for the expandable element integrated into the pushingelement, wherein the expandable element is shown contracted.

FIG. 8B shows the embodiment of FIG. 8A with the expandable elementexpanded.

FIG. 9 is a cross-sectional view of an embodiment of the device showingthe inclusion of a sliding bolt on the retractor element and relatedindexed slots on the pushing device.

FIG. 10 is a partial view the pushing element of FIG. 9 showing theindexed slots on the pushing device.

FIG. 11A is a perspective view of a flexible structural frame of anotherembodiment of the connector conduit shown in a straight configuration.

FIG. 11B is a perspective view of the structural frame of FIG. 11A shownin a bent configuration.

FIG. 11C is a perspective view of the structural frame of FIG. 11B shownwith a beveled and tapered leading edge.

FIG. 12 is a perspective view of an alternative embodiment of FIG. 10B.

FIG. 13A is a perspective view of the flexible structural frame of FIG.11B shown in the straightened configuration and incorporating a bendingmeans.

FIG. 13B is a perspective view of the structural frame of FIG. 13A afteractivating the bending means.

FIG. 14 is a perspective view of a non-bendable structural frame of aconnector conduit.

FIG. 15 is a cross-sectional view of a connector conduit shown in a bentconfiguration.

FIG. 16 is a cross-sectional view of a non-bendable connector conduit.

FIG. 17A is a cross-sectional view of a mounting element (including acoring element) and a pushing element of the applicator with a loadedconnector conduit.

FIG. 17B is a cross-sectional view FIG. 17A without the connectorconduit.

FIG. 18A is a perspective view of a squeeze ring for a locking means tosecure the connector conduit within the applicator.

FIG. 18B is a perspective view of a locking means shown in the lockedposition.

FIG. 18C is a perspective view of a locking means shown in the unlockedposition.

FIG. 19 is a cross-sectional view of the device of FIG. 17B including aretractor element.

FIG. 20 is a cross-sectional view of a folding and mounting tool.

FIG. 21 is a cross-sectional view of an assembly including an applicatorhaving a syringe.

FIG. 22A is a cross-sectional view of a sequencing belt.

FIG. 22B is a cross-sectional view of the retractor body and expandingelement.

FIG. 22C is a cross-sectional view of the positioning mans and coringelement.

FIGS. 23A-23C the sequencing can mechanism in various states.

FIGS. 24A-24E illustrate the applicator in various states.

FIG. 25 is a perspective view of an integrated connector conduit andcutting elements.

FIG. 26 is the device of FIG. 25 with the cutting element withdrawn.

FIG. 27A-27D illustrate components of a retractor having an expandableumbrella element.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is an illustration of an apicoaortic conduit, which extends fromthe apex of the left ventricle to the descending aorta with a prostheticvalve positioned within the conduit. The preferred embodiment of thepresent invention includes aspects of the connector conduit and anapplicator used to implant the connector conduit.

The connector-conduit with applicator of the present invention is bestdescribed as consisting of five major parts: a connector-conduit, aretractor, hole forming device such as a coring element, a pushingcomponent, and a handle. A fabric material pleated conduit of a typecommon and well known in the field is permanently fixed to the innersurface of a rigid connector to form the connector-conduit. The conduitextends from the forward edge of the connector and continues beyond theconnector, as a flexible portion, for some distance.

The connector-conduit includes a rigid portion defined by an internalsupport structure made of a suitably flexible material that ispreferentially biased to assume a bent configuration (such as a rightangle) upon removal of restraining forces. In one embodiment, theconnector internal support structure is covered with fabric, such asknitted or woven Dacron, for example. A suturing ring is integrated intothe covering fabric and provides a suitable flange for suturing theconnector to the surface of the heart. The leading edge of the connectoris tapered to facilitate insertion of the connector-conduit component.The “rigid” portion is rigid enough to facilitate insertion as describedbelow and to maintain the hole in an open position. However, the rigidportion can be flexible. Accordingly, the term “rigid” as defined hereinmeans relatively rigid and can include flexibility.

As shown in FIG. 2A, the structural frame 10 of the connector-conduit isa series of circular rings 14 joined to a curved spine 18. Duringimplantation, the curved spine 18 is straightened, as shown in FIG. 2B,resulting in a straight pathway for the passage of instruments. As analternative, the connector-conduit could include circular rings 14without curved spine 18. As such, the circular rings would preventcollapse of the conduit, but the curved conduit would be formed manuallyafter implantation, rather than by being formed by the curved spine 18.As another alternative, a modified coil spring in the shape of a curvecould be used instead of circular rings 14 and curved spine 18.Properties of the coil spring would be chosen to prevent radial collapseand to provide appropriate stiffness of the curved position.

The leading edge of structural frame 10 is a taper 20 which allows foreasy insertion of the connector through the ventricle wall. The materialof the structural frame 10 could be a shape memory alloy (e.g.,Nitinol), plastic, or other similar biocompatible material.

FIG. 3A illustrates a fabric covering 24 over the outside surface ofstructural frame 10. Because connector surface 22 is in contact with themyocardial hole after implantation, a suturing ring or flange 26 isincorporated into the fabric covering 24 to provide an attachment sitefor sutures to anchor the connector to the heart. The fabric coveredsuture ring 26 could be made of a biocompatible foam or rubber.

FIG. 3B shows the fabric covered structural frame 10 and suturing flange26 in a straightened position. The straightened position can be achievedby, for example, inserting a straight instrument through the lumen ofthe frame. Alternately, the structure can be held in the open positionthrough the use of stay stitches 28, or the like, placed such that thecircular rings 14 are held in close proximity.

FIG. 3C is a view similar to FIG. 3B, showing the structural frame inthe straightened position with a pleated fabric conduit 30. Conduit 30extends from taper 20 of the structural frame 10, through the length ofthe structural frame 10, and for some additional length beyond thestructural frame 10 to define a flexible portion of the connectorconduit. An orientation marker (not shown) on connector surface 22, forexample, is used to identify the direction that conduit 30 will beoriented once implanted into the heart. The orientation marker isvisible at all times to assist the surgeon while placing theconnector-conduit 32 into the connector-conduit applicator and tofacilitate implantation at an appropriate angle into the heart. Also, aradiopaque marker(s) (not shown) may be integrated into the entirelength of fabric covering 24 and conduit 30 to facilitate identificationand location of the structure by X-ray or other means.

Referring to FIG. 4, in accordance with another embodiment of thepresent invention, a hole forming device such as coring element 40, isplaced concentrically within the lumen of the connector-conduit 32. Thecoring element 40 preferably consists of a tubular structure, whichcould be made entirely of metal (such as stainless steel) or primarilyof a plastic material with a metal insert for the leading edge 42. In apreferred configuration, the leading edge 42 of coring element 40 may besuitably sharpened such that it cuts a plug of tissue of approximatelythe same diameter as the outer diameter of the coring element 40. Notethat the hole forming device can be any known mechanism for forming ahole, such as a laser cutter, a thermal ablation device, a chemicalablation device, or the like.

An interference fit between connector surface 22 and the hole created bythe coring element 40 is necessary to reduce bleeding from the cutmyocardial surface and to reduce blood leakage from the left ventricle.The amount of such interference fit is the difference between thediameters of the hole created by the coring element 40 and the outersurface of the connector 22.

In a preferred embodiment of the device, the coring element 40 has anouter diameter that closely matches the inner diameter of theconnector-conduit 32. Such construction allows removal of the coringelement 40 through the connector-conduit 32 while presenting only asmall blood pathway between these two elements. Such construction isintended to minimize blood loss from the left ventricle when the coringelement 40 has completed its cut.

FIG. 4 further illustrates the concentric placement of the retractorelement 50 within the coring element 40. Retractor element 50 includes ablunt tip 52, a tubular body 54, an expanding element 56, such as aballoon, and an access means 58 for engageably expanding element 56.Access means 58 can be a plunger 58 a in a cylinder 58 b configuration,whereby displacement of the plunger expands or contracts expandingelement 56. A centering plug 60 is shown concentrically positionedwithin and rigidly attached to coring element 40. The centering plug 60concentrically positions retractor element 50, which slideably moveswithin the centering plug 60. The centering plug 60 also presents abarrier to the flow of blood through coring element 40, once the tissueplug is formed. Proper placement of centering plug 60 within coringelement 40 should consider tradeoffs between two different parameters.First, centering plug 60 should be placed at a position within coringelement 40, which allows ample space for the expanding element 56 andthe tissue plug. Second, since radial force from the heart wall tends todeflect the expanding element 56, retractor element 50 must have asufficient stiffness to substantially resist such deflection. Suchdeflection may also be reduced by limiting the axial distance betweenthe expanding element 56 and centering plug 60.

FIG. 5 shows a cylinder plug tool 45 for insertion into coring element40 prior to loading connector-conduit 32 onto coring element 40.Cylinder plug tool 45 facilitates loading connector-conduit 32 withoutdamage from leading edge 42 of coring element 40. Once theconnector-conduit 32 is loaded, cylinder plug tool 45 is removed andplaced aside. As a safety measure, cylinder plug tool 45 has an extendedlength with a tapered blunted end 45 a, which extends to cover retractorelement 50, preventing insertion of the retractor element 50 into theleft ventricle before cylinder plug 45 is removed.

Referring to FIG. 6, another embodiment of the present invention shows acompression spring 70 placed around the retractor element 50. One end ofthe compression spring 70 seats on the centering plug 60, and the otherend seats on a sliding plug 72. Sliding plug 72 is rigidly connected toretractor element 50. Spring 70 ensures that expanding element 56 seatssnugly against the inside wall of the ventricle to symmetricallydisplace the ventricle wall from the path of the coring element. Oncethe tissue plug is cut from the ventricle by coring element 40, spring70 also pulls the tissue plug fully within the coring element 40.

FIG. 7 illustrates a further embodiment, wherein a cylinder-shapedpushing element 80 is positioned concentrically outside theconnector-conduit element 32. Pushing element 80 is used to apply forceto the coring element 40 and connector-conduit element 32. This force isrequired for the coring element 40 to cut the hole in the myocardium andfor pushing the connector-conduit element 32 into the hole. The end ofthe pushing element 80 that is in contact with the suture ring 26 has aroughened surface 82 intended to prevent relative rotary motion betweenthe suture ring 26 and pushing element 80. As such, the pushing element80 allows both a force and a back-and-forth rotary motion tosimultaneously be applied to the coring element 40 and connector-conduitelement 32, as required to fully seat the suture ring 26 flush with thesurface of the heart. Pushing element 80 could be made of metal, plasticor other suitable material.

Referring to FIGS. 8A and 8B, a handle 90 is rigidly attached to pushingelement 80. As shown, handle 90 is configured similar to a pistol grip,for example, handle 90 having an angle of about 70 degrees, with thepushing element 80. Handle 90 provides a user-friendly interface for thesurgeon to hold with one hand, to position the coring element 40, toapply axial force to the connector-conduit element and to provide aback-and-forth rotational motion of around 90 degrees. Of course, manyalternatives exist for the user interface. For example, the pushingelement 80 itself could be used as the handle. As another example, ahandle could form a “T” shape on the end of the pushing element 80.

Also shown in FIG. 8A, an access means 58 is used to expand or contractexpanding element 56. Access means 58, for example, can be atrigger-type mechanism integrated into handle 90. As such, the user canuse a finger to pull plunger 58 a into the cylinder 58 b, therebydisplacing the fluid (such as saline) inside the cylinder 58 b into theballoon 56. FIG. 8B shows the inflation of the balloon 56. As a safetyfeature, the plunger can have a latching device (not shown) that latchesthe plunger 58 a with the balloon fully inflated, thereby preventingdeflation of the balloon before intended.

FIGS. 9 and 10 show a mechanism for controlling deployment of theretractor element 50. A slot 84 is cut into pushing element 80. Slot 84has an index 84 a to lock retractor element 50 at full extension and anindex 84 b to lock retractor element 50 at full retraction. Bolt 72 a isrigidly attached to sliding plug 72. Bolt 72 a can be manually displacedwithin slot 84 to position the retractor element 50. In operation, bolt72 a is positioned in index 84 a until the retractor element 50 is fullyinserted into the left ventricle and the expanding element 56 is at fullexpansion. At that time, bolt 72 a is manually released from index 84 a,which allows compression spring 70 to retract retractor element 50 untilexpanding element 56 contacts the inside wall of the left ventricle. Adamping means (not shown) may be included to prevent sudden retractionof the retractor element upon release from index 84 a. Also not shown isa safety latch or other means to prevent manual release of the bolt 72 auntil the expanding element 56 is fully expanded.

As the surgeon applies force and rotation using handle 90, compressionspring 70 continues to displace retractor element 50. When retractorelement 50 is fully retracted, the surgeon can rotate bolt 72 a intoindex 84 b to lock the retractor element 50 in place. Moreover, whenretractor element 50 is fully retracted, the expanding element 56 isalso fully retracted into coring element 40, indicating that the tissueplug has been successfully removed from the left ventricle and is withinthe coring element 40.

Referring to the embodiment of FIGS. 11A-11C, the connector conduit hasa structural frame 101 defining a rigid portion, which may beconstructed from a single material or a combination of materials. Thestructural frame 101 includes a tapered leading edge 110 designed toreduce the effort needed to push the connector through the heart walllocated at one end of a cage section 120 and a bend portion 140 that isnormally biased into a bent configuration. As shown in FIG. 11C, atapered and beveled leading edge 150 may further reduce the requiredeffort. During use, cage 120 resides primarily within the heart wall, soit must be constructed so as to be rigid enough to not collapse due toradial forces exerted by the heart wall. The cage 120 may include cageslots 121. The cage slots 121 allow the passage of thread to secure theconduit or the sewing flange.

A holder 130 is formed at one end of cage 120 and may be used to graspthe connector during implantation. As will be described further herein,holder 130 can have a slot-and-key configuration with the applicator. Assuch, the holder 130 utilizes holder slots 431 or a holder button 430(FIG. 12). Holder button 430 may be a separate part that is anchored(e.g., by thread or glue) to structural frame 101. If desired, theholder slots 431 or holder button 430 may be designed to place theflexible bend 140 or rigid bend 145 (FIG. 14) at a preferred anglerelative to the applicator. Alternatively, the holder 130 may rely upona tight friction fit with the applicator. In a preferred configuration,the holder 130 relies upon both a slot-and-key and a tight friction fitto lock the holder 130 relative to the applicator.

Referring again to FIGS. 11A and 11B, bend portion 140 includes circularrings 141 and a curved spine 142. The circular rings 141 prevent radialcollapse of the conduit, and the curved spine 142 holds the conduit in apreferred shape to direct blood flow from the heart to the aorta. Thecurved spine 142 may be at the outer radius of bend portion 140 (asshown) or at the inner radius of the flexible bend. As an alternative,flexible bend 140 may include two curved spines at the mean radius. Asanother alternative, the structural frame 101 could include circularrings 141 without curved spine 142. As another alternative, a modifiedcoil spring in the shape of a preferred bend could be used instead ofcircular rings 141 and curved spine 142. Properties of the coil springwould be chosen to prevent radial collapse and to provide appropriatestiffness of the curved position.

The structural frame of FIGS. 11A-12 is intended for mounting onto theouter diameter of a straight mounting element. As such, the bend portion140 must be constructed to allow straightening of the curved spine 142.If curved spine 142 is made of a material or combination of materialswith higher modulus of elasticity (e.g., PEEK, metal), the flexible bend140 is stiffer. As such, the flexible bend 140 may be biased to resume apreferred shape (e.g., a 90° bend) when removed from the mountingelement. If the curved spine 142 is made of a material with a lowermodulus of elasticity (e.g., polypropylene, polyethylene), the bendportion 140 is less stiff. As such, the bend portion 140 may be biasedrelatively straight when removed from the straight mounting element. Insuch case, some bending means may be needed to position the bend portion140 into the preferred shape.

One embodiment of a bending means is shown in FIGS. 13A and 13B, whichillustrate use of threads 143 that are secured to the holder 130 (forexample) and weaved through circular rings 141. When threads 143 arepulled, the bend portion 140 changes from the normally biased, straightconfiguration of FIG. 13A to the bent configuration of FIG. 13B. Whenthe flexible bend 140 reaches the preferred shape, the threads may betied to form a knot or crimped. If desired, the bending means can beused with a curved spine 142 constructed of a high modulus of elasticitymaterial to prevent straightening beyond the preferred angle.

As discussed previously, structural frame 101 may be constructed with afixed bend 145, as shown in FIG. 14. A port 146 allows the mounting ofstructural frame 101 with a fixed bend 145 onto a straight mountingelement.

FIG. 15 is a cross-section of a connector conduit 100 that includes arigid portion defined by structural frame 101 with bend portion 140, anda flexible portion defined by conduit 160. The rigid portion alsoincludes outer fabric 161, and sewing flange 170. Orientation marks (notshown) may be included on the conduit 160 or outer fabric 161. Conduit160 may be a pleated vascular graft constructed of woven Dacron. Outerfabric 161 could be a knitted Dacron fabric material that stretches toaccommodate contours of the structural frame 101. Sewing flange 170could be constructed of a soft silicone rubber, for example, to alloweasy passage of a needle when fastening sewing flange (or sewing ring)170 to the outer surface of the heart. To allow visualization on x-ray,for example, the sewing flange could be made radiopaque, such as bymixing barium sulfate into the silicone rubber. The sewing flange mayhave a cloth covering such as that used for outer fabric 161.Alternatively, the sewing flange 170 may consist entirely of foldedcloth. The components of the connector conduit 100 may be fastenedtogether as needed, such as with thread.

Referring to FIG. 16, a cross-section of a connector conduit 100 issimilar to that shown in FIG. 15, except that the structural frame 101is constructed with fixed bend 145. A conduit branch 162 intersects withconduit 160 through port 146 of rigid bend 145 to allow passage of astraight mounting element through the connector conduit 100. Once theconnector conduit 100 is implanted into the ventricle, branch 162 may beoccluded at the intersection with conduit 160. Branch 162 may then becut off.

FIG. 15 and FIG. 16 further illustrate a quick connect coupler 180 forexpediting attachment of the connector conduit 100 to the remainder ofthe prosthesis, which may include a prosthetic valve or ventricularassist device, as examples. As shown, the male end of quick connectcoupler 180 is a continuation of or is attached to vascular graft 160.The male end of quick connect coupler 180 includes rigid connector frame181, which may be constructed of a biocompatible plastic or metal.Vascular graft 160 covers the inner diameter of connector frame 181, andan outer fabric 165 covers the outer diameter of connector frame 181.Outer fabric 165 may be continuous with vascular graft 160. Outer fabric165 is not of a pleated construction, such as is typical of vasculargraft 160. The cloth-covered connector frame 181 provides a rigidsurface onto which the female end of quick connect coupler 180 may bemounted. The female end of quick connect coupler 180 includes vasculargraft 186 and pull ring 185. Vascular graft 186 attaches on itsdownstream end to the remainder of the prosthesis, which may include aprosthetic valve or ventricular assist device, as examples. Vasculargraft 186 may be a pleated vascular graft constructed of woven Dacron,for example. Graft extension 186 a is a continuation portion of or isattached to vascular graft 186. A rigid pull ring 185 (which may beconstructed of a biocompatible plastic or metal) is attached to graftextension 186 a. The male end of quick connect coupler 180 has a largerouter diameter than vascular graft 186. This construction provides astop so that the male end of quick connect coupler 180 reaches an abruptchange to a smaller diameter provided by vascular graft 186. In thisway, the surgeon knows when the male end is fully inserted into thefemale end of quick connect coupler 180. In use, the surgeon may grasppull ring 185 with one hand and connector frame segment 181 a ofconnector frame 181 with the other hand. Pull ring 185 is pulled overouter fabric 165 until the male end of quick connect coupler 180contacts the smaller diameter vascular graft 186. A large suture orumbilical tape 187 may then be tied around graft extension 186 a toreduce blood loss by occluding the annular gap between the outerdiameter of outer fabric 165 and the inner diameter of graft extension186 a. Stay sutures may also be used to connect outer fabric 165 tograft extension 186 a, thereby preventing separation of the male andfemale ends of quick connect coupler 180.

FIG. 15 and FIG. 16 further illustrate a collapsible portion 160 abetween connector conduit 100 and quick connect coupler 180. Suchcollapsible portion 160 a allows use of a cross clamp, for example, tofully collapse portion 160 a to occlude flow after the applicator isremoved beyond collapsible portion 160 a. Collapsible portion 160 a canbe made of the same material as the rest of the flexible portion, or canbe made of a different material.

In use, the applicator of the present invention is used to implant theconnector conduit 100 into the ventricle wall or other organ wall. FIG.17A shows a cross-section of the connector conduit 100 (FIG. 15) loadedonto a mounting element 200. For clarity, the applicator is shownwithout the connector conduit 100 in FIG. 17B. Mounting element 200includes a cylindrical coring element 210, serving as a hole formingelement, that is concentric with and has the same diameter as themounting element 200. The mounting element 200 and coring element 210are placed concentrically within the lumen of the connector conduit 100.Coring element 210 includes a thin-walled tube and a sharpened cuttingedge 210 a, which may be tapered on the inner diameter, for example, toform the sharpened cutting edge 210 a. The coring element 210 is used tocut a cylindrical-shaped core (or hole) in the heart wall, producing aplug from the heart wall that resides within the coring element 210. Themounting element 200 could be constructed of plastic (e.g., ABS), andthe coring element 210 could be constructed of metal (e.g., stainlesssteel). In a preferred embodiment, the mounting element 200 and coringelement 210 have an outer diameter that closely matches the innerdiameter of the connector conduit 100. One purpose of such aconstruction is to minimize blood loss from the left ventricular chamberwhen the coring element 210 has completed its cut. Also in order toreduce blood loss from the left ventricular chamber and from the cutmyocardial surface and to yield a snug fit of the connector conduitwithin the ventricular myocardium, the cutting diameter of the coringelement 210 is chosen to produce a core that is smaller in diameter thanthe outer surface 163 of the of the connector conduit 100.

FIG. 17A and FIG. 17B further illustrate a cylinder-shaped pushingelement 300 positioned concentrically outside the connector conduit 100.In a preferred embodiment, the pushing element 300 transmits pushingforce and rotation to the connector conduit 100. In further accordancewith a preferred embodiment, the pushing element 300 is rigidly attachedto mounting element 200, such that pushing element 300 transmits pushingforce and rotation to the mounting element 200 and coring element 210.Pushing element 300 may be constructed of plastic (e.g., ABS) or metal(e.g., stainless steel). However, it should be appreciated that thepresent invention contemplates the use of other materials.

In further accordance with a preferred embodiment, a locking meansprovides an interface that prevents movement of the connector conduit100 relative to the pushing element 300. Such locking means may includecomponents that are integral with the pushing element 300, connectorconduit 100, mounting element 200, and coring element 210. FIGS. 18A to18C illustrate one embodiment of such a locking means. This embodimentcombines a slot-and-key arrangement with a friction enhancingarrangement. The slot-and-key arrangement includes notch 421 (the slot)of pushing element 300 and holder button 430 (the key) of structuralframe 101. Positioning holder button 430 into notch 421 preventsrotation of connector conduit 100 relative to pushing element 300 andprevents axial motion in one direction. Axial motion allowing removal ofthe connector conduit 100 from the applicator is not prevented in thisembodiment. Rather, this axial motion is reduced by providing a frictionenhancing arrangement consisting of squeeze ring 410 (which includes twogroove pins 411) and squeeze arms 425 a and 425 b that cantilever frompushing element 300 to form wide groove 420 a and narrow groove 420 b.Alternatively, notch 421 could fit tightly around the circumference ofholder button 430 to prevent movement of the connector conduit 100relative to the pushing element 300 in both rotational and axialdirections. As shown, notch 421 is divided, with one half cut fromsqueeze arm 425 a and the other half from squeeze arm 425 b.Alternatively, notch 421 could reside entirely within either squeezearm. Alternatively, several notches 421 could be used.

When squeeze ring 410 is positioned at or near notch 421 as shown inFIG. 18B, squeeze ring 410 holds squeeze arms 425 a and 425 b tightlyagainst connector conduit 100, creating a tight friction fit. In thisposition, groove pins 411 within wide groove 420 a do not tend toseparate squeeze arms 425 a and 425 b. When squeeze ring 410 ispositioned as shown in FIG. 18C, groove pins 411 within narrow groove420 b tend to separate squeeze arm 425 a and 425 b to allow theconnector conduit to be easily moved into position or removed. In asimilar embodiment (not shown), the slot-and-key arrangement couldinclude teeth (keys) that extend radially inwards from the innerdiameter of squeeze arms 425 a and 425 b to fit into holder slots 431 ofholder 130 of structural frame 101 (see FIG. 11A). In this embodiment, asqueeze ring (with groove pins) and squeeze arms similar to those shownin FIGS. 18A to 18C would be used to engage and disengage the teeth fromholder slots 431, rather than to provide a tight friction fit.

In accordance with a further embodiment of the present invention, aretractor component element 500 with a generally tubular structure islocated concentrically within the mounting element 200, as shown in FIG.19. The retractor element 500 can slide axially relative to the mountingelement 200. The retractor element 500 consists of a blunt tip 510, atubular body 520, and an expanding element 530 that includes an accesspassage 531. The expanding element 530 is shown as a balloon in FIG. 19,which may be inflated and deflated with fluid (e.g., saline) throughaccess passage 531 using a plunger and cylinder arrangement.

Retractor element 500 is held concentric within the mounting element 200by centering plug 220 and sliding plug 521. Centering plug 220 isrigidly attached to mounting element 200, and sliding plug 521 isrigidly attached to tubular body 520. Since radial force from the heartwall tends to deflect the expanding element 530, tubular body 520 musthave a sufficient stiffness to substantially resist such deflection.Such deflection may also be reduced by limiting the axial distancebetween the expanding element 530 and centering plug 220.

A coupling element, such as compression spring 540, slideably couplesretractor element 500 to mounting element 200. Compression spring 540biases refractor element proximally to ensure that expanding element 530seats snugly against the inside wall of the ventricle to shape andpartially flatten the ventricle wall (particularly at the apex) so thatcoring element 210 may cut perpendicular to the ventricle wall. Once thetissue plug is cut from the ventricle by coring element 210, spring 540pulls the tissue plug fully within the coring element 210. In thepreferred embodiment, expanding element 530 is a balloon in the shape ofa circular torrid.

FIG. 20 illustrates a mounting and folding tool 900, which includescoring element taper 910, balloon taper 920, conduit taper 930, andretractor element port 940. Tool 900's outer diameter may be equal to orslightly larger than coring element 210's outer diameter to preventdamage to fabrics of the vascular graft 160 and outer fabric 161, whenthe connector conduit 100 is being mounted onto or demounted frommounting element 200. As an alternative, a thin-walled tube, such as aplastic shrink rube, may be positioned over outer diameters of tool 900and coring element 210 to further prevent damage to fabrics slid pastthe sharpened edge 210 a of the coring element. Coring element taper 910fits snugly within coring element 210 to ensure a concentric fit betweentool 900 and coring element 210, thereby further reducing the likelihoodof damage to vascular graft 160 and outer fabric 161. Conduit taper 930eases placement of vascular graft 160 onto tool 900. Tool 900 may beused to deflate and fold expanding element 530 by placing tool 900 ontoretractor element 500 and by pushing and rotating (in one direction)tool 900 until coring element taper 910 contacts coring element 210.Balloon taper 920 provides a surface for controlled deflation andfolding of the expanding element 530. Once the balloon is deflated andfolded and the connector conduit 100 is fully mounted onto theapplicator, tool 900 may be removed.

FIG. 21 illustrates an embodiment of an applicator assembly (connectorconduit 100 not shown). In this assembly, the surgeon has independentcontrol of the position of retractor element 500 and the volume ofexpanding element 530. Handle 310, which extends from pushing element300 to form a pistol grip, provides a means for the surgeon to applyaxial force and back-and-forth rotary motion while implanting connectorconduit 100. The position of retractor element 500 is controlled by theposition of retractor bolt 522 in slot 320 of pushing element 300.Retractor bolt 522 is rigidly attached to sliding plug 521 of retractorelement 500. Slot 320 is extended circumferentially to form index 321,which may be used to hold the retractor element 500 fully extended(i.e., with expanding element 530 at maximum distance from coringelement 210). Expanding element 530 is connected to cylinder 562 byaccess passage 531 and flexible tube 550. Expanding element 530 volumeis controlled by the position of plunger 600 in cylinder 562. Cylinder562 is oriented in handle 310 so that plunger 600 with trigger 563 formsa pistol handle with trigger arrangement. Expanding element 530 can beinflated with saline, when trigger 563 is squeezed. Plunger spring 565may be used to deflate expanding element 530 when the trigger isreleased. Alternatively, trigger 563 could be replaced with a fingerring so that the user must apply force to control both inflation anddeflation of expanding element 530, thereby eliminating the need forplunger spring 565. As a safety feature, the plunger 600 may include alatching device (not shown) that latches the plunger 600 with theballoon fully inflated, thereby preventing premature deflation of theballoon. A related safety feature may include another latching device(not shown) that latches plunger 600 with the balloon partiallyinflated, such as to prevent the tissue plug from coming off ofretractor element 500. As one of many alternatives to handle 310, thehandle could form a “T” with pushing element 300.

In operation, retractor bolt 522 is positioned in index 321 until theretractor element 500 is fully inserted into the ventricle and expandingelement 530 is fully inflated. At that time, retractor bolt 522 ismanually released from index 321, which allows compression spring 540 toretract retractor element 500 until expanding element 530 contacts theinside wall of the ventricle. A damping means (not shown) may beincluded to prevent sudden retraction of the retractor element 500 uponrelease from index 321. Also not shown is a safety latch or other meansto prevent manual release of the retractor bolt 522 until the expandingelement 530 is fully expanded. As the surgeon applies force and rotationusing handle 310, compression spring 540 continues to displace retractorelement 500. When retractor element 500 is fully retracted, expandingelement 530 is also fully retracted to within coring element 210,indicating that the tissue plug has been successfully removed from theleft ventricle and is within the coring element 210.

FIG. 22A to FIG. 22C are components of a preferred embodiment shown inFIGS. 24A-24E, that uses a sequencing element to coordinate the positionof refractor element 500 with the expansion of expanding element 530(FIG. 22B). In this embodiment, the sequencing element is a cammechanism. The cam mechanism helps to ensure proper use of theapplicator during implantation of connector conduit 100 (not shown). Asshown in FIG. 22B, retractor element 500, referred to as the retractorassembly, includes cylinder portion 562 integrated therein. Theretractor assembly is positioned concentrically within pushing element300 during use. The retractor assembly contains elements of the cammechanism formal therein, including cylinder cam slot 710, which is aslot cut completely through the cylinder 562 wall, and a refractor camfollower 760, which may be a pin or screw in cylinder 562 (as shown) ormay be an integral part of cylinder 562. Retractor element 500 mayinclude a section of increased diameter such as stopper disk 515 toprevent cutter element 210 from cutting the heart when retractor element500 is initially inserted. FIG. 22A illustrates plunger 600 (in the formof a sequencing bolt as described below), which is positionedconcentrically within cylinder 562 during use. Plunger 600 containselements of the cam mechanism, including bolt portion 650 with plungercam follower 750. Plunger cam follower 750 moves within cylinder camslot 710 and pusher cam slot 720. Plunger 600 includes passage 610 andpurge/fill valve 630 (valve body not shown). Valve 630 can be opened toallow fluid flow into and out of passage 610. When closed, valve 630allows no fluid flow in either direction. Valve 630 may be connected(such as with a catheter) to a reservoir of saline, for example, topurge the expanding element 530, access passage 531 and any other volumein the flow circuit of air before filling these volumes with fluid (suchas saline). O-ring groove 620 of plunger 600 contains an o-ring (notshown) to prevent loss of fluid.

FIG. 22C illustrates a positioning assembly, which is made up of rigidlyconnected components including pushing element 300, cutting element 210,and handle 310. The pusher assembly contains elements of the cammechanism, including pusher cam slot 720 and retractor cam slot 730. Thepusher cam slot 720 is a slot cut completely through the pushing element300 wall to accommodate plunger cam follower 750.

FIG. 23A to FIG. 23C illustrate operation of the cam mechanism. FIG. 23Aillustrates cylinder cam slot 710 cut into cylinder 562 of FIG. 22B.Cylinder cam slot 710 contains three interconnected axial cam slots atangles ₁, ₂ and ₃ around the circumference of cylinder 562, as furtherillustrated in FIG. 23C. The axial cam slot at each angle corresponds toa range of allowable axial positions of plunger 600 within cylinder 562.At angle ₁, the axial length of the cam slot corresponds to the maximumstroke of plunger 600 within cylinder 562. This maximum stroke allowsfilling the expanding element 530 from minimum volume to maximum volume.At angle ₂, the axial cam slot allows plunger 600 movement to provideexpanding element 530 volumes ranging from maximum volume to anintermediate volume (at an intermediate stroke) that is greater thanminimum volume but less than maximum volume. At angle ₃, the axial camslot retains plunger 600 at the position of maximum volume of theexpanding element 530. FIG. 23A also illustrates positions A, B, C, Dand E of plunger cam follower 750 within cylinder cam slot 710 duringthe steps of operation.

FIG. 23B illustrates pusher cam slot 720 and retractor cam slot 730 cutinto the pusher assembly of FIG. 22C. FIG. 23B also illustratespositions A, B, C, D and E of plunger cam follower 750 within pusher camslot 720 and retractor cam follower 760 within retractor cam slot 730during the steps of operation. FIG. 23C illustrates angles ₁ to ₆ forcylinder 562 and the pusher assembly. For purposes of description, thevalue of the angles increases from ₁ to ₆. Pusher cam slot 720 includesangles ₁ and ₃, which may correspond with angles ₁ and ₃ of cylinder 562(see FIG. 23A). Pusher cam slot 720 includes angle ₄, which is largerthan ₃. The axial length of pusher cam slot 720 from position A toposition B corresponds to the maximum stroke of the plunger 600, asdescribed above. The axial length of pusher cam slot 720 from position Cto position E corresponds to the intermediate stroke (as describedabove) plus the axial distance traversed by retractor cam follower 760from position C to position E in retractor cam slot 730. Retractor camslot 730 includes angles ₅ and ₆. Positions A and B at angle ₅ preventcompression spring 540 from displacing cylinder 562 within the pusherassembly.

In operation, retractor cam slot 730 controls the motion of cylinder 562within the pusher assembly. As shown in FIG. 23A and FIG. 23B, whenplunger cam follower 750 (of sequencing bolt 600) is movedcircumferentially from position B to position C in both cylinder camslot 710 and pusher cam slot 720, retractor earn follower 760 is forcedfrom position B to position C in retractor cam slot 730, which allowscompression spring 540 (see FIG. 19) to push cylinder 562 axially withinthe pusher assembly. Retractor cam follower 760 within retractor camslot 730 holds cylinder 562 at a constant angular position relative tothe pusher assembly during movement from position C to positions D andE; therefore, movement of plunger cam follower 750 from position C toposition D within pusher cam slot 720 forces cam follower 750 into theaxial slot corresponding to angle ₂ of cylinder 562.

Referring to FIGS. 24A to 24E, the applicator of the present inventionis shown at various steps during use. Note that these figures do notinclude details of the locking means to securely hold the connectorconduit 100. FIG. 24A to FIG. 24E correspond to positions A to E,respectively, which are described in FIG. 23A to FIG. 23C. Recognizingthat individual surgeons may find alternative steps to properly use theinvention, a representative sequence of steps for use of the applicatorto implant a connector conduit is described. These steps include firstpreparing the applicator with the connector conduit. With the retractorassembly in the fully extended position as shown in FIG. 24A, a mountingand folding tool 900 is positioned into the coring element 210, as shownin FIG. 20. The connector conduit 100 of FIG. 15 is then loaded into theapplicator by sliding connector conduit 100 over the folding tool 900until sewing flange 170 contacts notch 421 (see FIG. 18). The connectorconduit is then locked into place using the locking means. Tool 900 isthen removed. A catheter is attached to purge/fill valve 630 and to areservoir of saline. Valve 630 is opened. Sequencing bolt 600 is thenmoved back and forth from position A to position B several times topurge the fluid system of air and to fill the system with fluid, such assaline. Once the air is purged, sequencing bolt 600 is placed atposition A, and tool 900 is again positioned into the coring element210—this time to squeeze fluid from the balloon and to fold the balloon.When tool 900 is in place, valve 630 is closed, and the catheter isremoved. Tool 900 is removed. The applicator with connector conduit isnow ready for use, as shown in FIG. 24A.

Before implanting the connector conduit 100 into the ventricle wall, theportion of the prosthesis that includes the prosthetic valve orventricular assist device, as examples, is connected to the aorta. Thisportion of the prosthesis also includes the female end of quick connectcoupler 180. By implanting this portion of the prosthesis first, thetime between insulting the heart by cutting a hole and beginning bloodflow through the complete prosthesis is minimized.

A template with similar dimensions as connector conduit 100 is placed onthe apex of the heart, and a marker is used to trace the circularoutline of the connector onto the apex, in the planned location ofinsertion. Multiple (8 to 12) large pledgeted sutures (mattress sutures)of for example, 2-0 prolene, are placed in the apex surrounding themarked circle. With the connector conduit 100 loaded in the applicatorof FIG. 24A, the sutures are brought through sewing flange 170 of theconnector conduit 100. A knife is used to make a stab wound in the apexat the center of the circle. With the applicator in the position shownin FIG. 24A, blunt tip 510 of retractor element 500 is inserted into thestab wound and pushed through the apex into the left ventricle chamberuntil stopper disk 515 contacts the epicardium (outside surface of theheart). Sequencing bolt 600 is moved from position A to position B toinflate the balloon behind tissue T of the heart wall (see FIG. 24B).The surgeon moves sequencing bolt 600 from position B to position C (seeFIG. 24C) and then releases sequencing bolt 650. Beginning at position Cof FIG. 24C, compression spring 540 pushes the retractor assembly fromposition C to position D (see FIG. 24D). When the retractor assemblymoves from position C to position D, tissue T of the heart wall is firstsandwiched between the balloon and the sharpened edge of the coringelement 210 a. By the surgeon using handle 310 to apply axial force andback-and-forth rotary motion, the sharpened edge of the coring element210 a cuts though the heart wall to form a plug of tissue T that residesin the coring element 210. At position D, the retractor assembly hasbeen retracted until the balloon is in contact with coring element 210and the tissue plug is fully within coring element 210. Also at positionD, cylinder cam slot 710 has forced plunger cam follower 750circumferentially to angle ₂, thereby allowing deflation of the balloonto begin. Between position D (FIG. 24D) and position E (FIG. 24E), theballoon deflates to the intermediate volume (described earlier), and theretractor assembly retracts to its final position. If necessary, thesurgeon may pull sequencing bolt 600 to its final position E.

Connector conduit 100 is now fully implanted. The sutures are tied, andhemostasis is checked. Additional sutures may be placed if needed. Thelocking means (not shown) holding the connector conduit in theapplicator is released, and the applicator is partially removed to aposition where a clamp can be placed directly on collapsible graft 160 ato prevent blood flow through the conduit 160. Once the clamp is inplace, the applicator may be completely removed from connector conduit100. The male and female ends of quick connect coupler 180 may now beconnected. Umbilical tape 187 may be tied around graft extension 186 ato reduce any blood leakage, and stay sutures may be used to securegraft extension 186 a to outer fabric 165. Once the flow passage of theprosthesis is purged of air, the clamp may be released to allow bloodflow through the prosthesis. Flexible bend 140 is formed by pullingthreads 143 and tying a knot. The connector conduit 100 is now fullyimplanted.

As illustrated in FIG. 27, an alternative embodiment, can use aconnector conduit having and integral hole forming element. Hole formingelement 21′ is integrally formed, i.e. formed as a single component,with respect to connector conduit 100′. Connector conduit 100′ can beloaded on an applicator (not having a separate hole forming element) ina manner similar to that disclosed above. After forming the hole andinserting the connector conduit into the hole, hole forming element 210′can be withdrawn into a distal end of connector conduit 100′, asillustrated in FIG. 26, to reduce the possibility of unintended tissuedamage. Such withdrawal can be accomplished by the sequencing means, amanual mechanism on the applicator, or with a separate instrument.

In the preferred embodiment described above, the expansion element is aballoon. However, an alternative expansion element, in the form of anumbrella mechanism, is illustrated in FIGS. 27A-27D. Retractor 500′includes cylinder 810 (shown in cross section), and piston element 820slideably disposed in cylinder 810. Bolt 650 having follower 750 isformed on cylinder 810. Shaft 830 extends from piston element 820 andhas umbrella mechanism 850 formed on an end thereof. Umbrella mechanism85 included plural bendable leaf elements 852 that are fixed to shaft830 at the end of shaft 830. Leaf elements 852 are fixed to ring 854 atthe other end thereof. Ring 854 is slideably disposed on shaft 830.Accordingly, movement of shaft 830 to the right in the FIGS. causes ring854 to be pushed toward the end of shaft 830 as ring 854 abuts an end ofcylinder 810, as shown in FIG. 27 D. Slot 710 guides follower 750, adbolt 650 cooperates with remaining elements in the sequencing mechanismin the manner described above, to coordinate the expansion state ofexpansion element 850.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art. It ispreferred therefore, that the present invention be limited not by thespecific disclosure herein, but only by the appended claims.

1-96. (canceled)
 97. A method for using an applicator to form a hole ina wall of a hollow organ and insert a connector conduit into the hole,said applicator comprising a hole forming element having a cuttingelement on a distal end thereof and being coupled to the connectorconduit with a distal end of said connector conduit being adjacent saidcutting element, a retractor element having an expansion element, andsequencing means for coordinating the relative movement of saidretractor element with respect to said hole forming element, said methodcomprising: a) inserting a distal end of the retractor element through aslit formed in the wall of the organ while the retractor element islocked in a fully extended position relative to the hole forming elementand the expansion element is in an unexpanded state b) expanding theexpansion element to a fully expanded state and moving the expansionelement toward the hole forming element; c) forming the whole with thecutting element and inserting the connector conduit into the hole bymanipulating the hole forming element while the expansion elementpresses the tissue toward the cutting element; d) decreasing the size ofthe expansion element to a partially expanded state and moving theexpansion element to be at least partially disposed in the hole formingelement; and e) decoupling the applicator from the connector conduit toremove the applicator while the connector conduit remains in the hole.98. The method of claim 97, wherein said cutting element is a cuttingblade formed on a distal portion of said hole forming element andwherein said forming step comprises pressing a cutting blade into thetissue and applying torsional force to the cutting blade.
 99. The methodof claim 97, further comprising occluding blood flow through theapplicator to create substantial hemostasis throughout a procedure forimplanting the connector conduit within the organ wall while the organremains at substantially normal physiological pressures.
 100. The methodof claim 97, wherein said hole forming element and said connectorconduit are fixed relative to one another said forming step.
 101. Themethod of claim 97, wherein said expansion element is a balloon. 102.The method of claim 101, wherein said balloon is in the shape of acircular toroid.
 103. The method of claim 97, wherein said expansionelement is an expandable sponge.
 104. The method of claim 97, whereinsaid expansion element is an umbrella mechanism.
 105. The method ofclaim 97, wherein said sequencing means comprises a cam mechanism. 106.The method of claim 97, wherein said sequencing means comprises a gearmechanism.
 108. The method of claim 97, wherein said sequencing meanscomprises at least one servo mechanism operatively coupled to thepositioning means and a controller operatively coupled to said at leastone servo mechanism.
 109. The method of claim 108, wherein saidcontroller mechanism comprises a microprocessor based device.
 110. Themethod of claim 109, further comprising a button operatively coupled tosaid sequencing means for activating said sequencing means upondepression of the button to thereby accomplish steps of a procedure forimplanting the connector conduit within the organ wall.